27-45 岁女性与 16-26 岁女性相比，九价人乳头瘤病毒疫苗的免疫原性和安全性：一项开放性 3 期研究。
Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study.
机构信息
Medical University of Vienna, Department of Gynecology and Obstetrics, Comprehensive Cancer Center, Vienna, Austria.
Centre d'Atèncio Primària, EBA Centelles, Barcelona, Spain.
出版信息
Vaccine. 2021 May 12;39(20):2800-2809. doi: 10.1016/j.vaccine.2021.01.074. Epub 2021 Mar 3.
BACKGROUND
Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16-26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26 years of age.
METHODS
This international, open-label study (NCT03158220) was conducted in women 16-45 years of age. Participants (16-26 years, n = 570 and 27-45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study.
RESULTS
At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45 years were compared to those in women 16-26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27-45 years to 16-26 years) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16-26 years, and 85.2% and 24.1% of women 27-45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study.
CONCLUSIONS
The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45 years compared with women 16-26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16-26 years to women 27-45 years of age. Clinical trial registration NCT03158220.
背景
九价人乳头瘤病毒（HPV；HPV 型 6/11/16/18/31/33/45/52/58）疫苗在一项针对 16-26 岁女性的 3 期研究中证明了其疗效。我们报告了一项针对 27-45 岁和 16-26 岁女性的九价 HPV 疫苗的 3 期免疫原性和安全性研究。
方法
这是一项国际性、开放性标签研究（NCT03158220），纳入了 16-45 岁的女性参与者。16-26 岁（n=570）和 27-45 岁（n=642）的参与者接受三剂九价 HPV 疫苗接种方案（第 1 天、第 2 个月、第 6 个月）。第 7 个月时评估 HPV 6/11/16/18/31/33/45/52/58 的几何平均滴度（GMT）和血清转化率。在整个研究期间，参与者都接受安全性随访。
结果
在第 7 个月时，27-45 岁女性的 HPV 6/11/16/18/31/33/45/52/58 的抗-HPV GMT 与 16-26 岁女性进行了比较。年龄较大的女性与年龄较小的女性相比，HPV 16/18/31/33/45/52/58 的抗-HPV GMT 非劣效性假设成立。HPV 类型不同，GMT 比值的 95%置信区间（27-45 岁至 16-26 岁）下限为 0.60-0.67，均超过所有 HPV 类型的 0.5 非劣效性边界。27-45 岁女性在第 7 个月时的血清转化率为所有 HPV 类型均>99%。16-26 岁女性中，87.5%出现注射部位和疫苗相关的全身不良事件（AE），25.1%出现疫苗相关的全身 AE；27-45 岁女性中，85.2%出现注射部位和疫苗相关的全身 AE，24.1%出现疫苗相关的全身 AE；研究期间未报告疫苗相关严重 AE，也未发生死亡。
结论
九价 HPV 疫苗在 HPV 16/18/31/33/45/52/58 方面，在 27-45 岁女性中诱导的抗-HPV GMT 与 16-26 岁女性相当。该疫苗总体耐受性良好，各年龄组的 AE 谱相似。这些数据支持将 16-26 岁女性的九价 HPV 疫苗疗效发现扩展到 27-45 岁女性。临床试验注册 NCT03158220。
Zotero 插件